Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "Senate Bill Undermines FDA Regulatory Role."

Following is an excerpt:

Senators Deb Fischer (R-Neb.) and Angus King (I-Maine) announced that they introduced a bill -- the Preventing Regulatory Overreach To Enhance Care Technology (PROTECT) Act of 2014--that targets the FDA's role. Like its companion bill in the House, the PROTECT Act in the Senate tries to paint a picture of the FDA as a maniacal, overreaching regulatory agency that is stifling innovation in the nascent mHealth industry. ...

"The biggest issue with both the SOFTWARE Act and the PROTECT Act is that it would deregulate certain standalone software used for such things as guiding therapeutic decision-making," Bradley Merrill Thompson, the mHealth Regulatory Coalition's general counsel, told FierceMobileHealthcare. "For example, under both acts, a radiation dosage calculator would be removed from FDA regulation even though there is considerable risk in using such a program." ...

"Fundamentally the Senate legislation would make NIST responsible for technical standards and take FDA completely out of the equation," said Thompson. "That's just a terrible idea. FDA has a lot of experience in this area. They also have statutory authority that would be useful to regulating certain types of high risk health IT."

Jump to Page

Privacy Preference Center

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.